Registry of Myelodysplastic Syndromes and Therapy-related Acute Myeloid Leukemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGroupe Francophone des Myelodysplasies
About this trial
The Registry MDS is an ongoing, observational study that has collected longitudinal data on diagnostics, demographics, clinical parameters, and health Care Interventions (HCI) from patients with MDS and therapy-related acute myeloid leukemia
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female
Age > 18 years
Patients with myelodysplastic syndrome and therapy-related acute myeloid leukemia
Able and willing to provide written informed consent
Disqualifiers
Age <18 years
Patient is unwilling or unable to give consent
Trial population
Included in the "Registry" are all patients over 18 years of age with myelodysplastic syndrome and therapy-related acute myeloid leukemia
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Hemoglobin level Unit of Measure g/dL
Hemoglobin concentration in patients at the time of inclusion.
Time frame
At enrollment2
Absolute neutrophil count / Unit of Measure G/L
Neutrophil count measured at baseline
Time frame
At enrollment3
Platelet count Unit of Measure / Unit of Measure: %G/L
Neutrophil count measured at baseline
Time frame
At enrollment4
Percentage of bone marrow blasts at enrollment / Unit of Measure: percent
Proportion of blasts in bone marrow aspirate
Time frame
At enrollmentSecondary outcomes
1
Overall survival
Time from diagnosis to death from any cause or last follow-up Progression-free survival Bone marrow failure (anemia, neutropenia and thrombocytopenia) Treatment duration and time response Time to IPSS progression, Rate and time to AML evolution Time-to-transfusion dependency Cytogenetic and molecular response
Time frame
From diagnosis until death or last follow-up, up to 120 months2
Progression-free survival
Time from diagnosis to progression to higher-risk MDS, transformation to AML, or death from any cause
Time frame
From diagnosis until progression, AML transformation, or death, assessed up to 120 months3
Incidence of bone marrow failure events (anemia, neutropenia, thrombocytopenia)
Number of patients presenting with hemoglobin \<10 g/dL, neutrophils \<1.0 G/L, or platelets \<100 G/L during follow-up.
Time frame
From diagnosis until last follow-up, up to 120 months4
Duration of first-line treatment for MDS
Time from initiation to discontinuation of the first-line therapeutic regimen
Time frame
From treatment initiation until discontinuation or last follow-up, assessed up to 60 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov